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The EUROIMMUN Anti-PLA2R ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-PLA2R ELISA (IgG) consists of a microwell ELISA plate coated with PLA2R antigen, 5 calibrators, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

The acceptance criteria and study proving the device meets them are detailed below for the EUROIMMUN Anti-PLA2R ELISA (IgG).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Reproducibility (Intra-Assay): 20 determinations for RU/ml based results, 20 determinations for Ratio based results.
• Reproducibility (Inter-Assay): 30 determinations for RU/ml based results, 30 determinations for Ratio based results.
• Repeatability (Total Imprecision): 150 determinations per sample for RU/ml and Ratio based results.
• Reproducibility (Lot-to-Lot): 18 determinations per sample for RU/ml and Ratio based results.
• Linearity/Assay Reportable Range: Five sets of 11-step-wise dilutions (totaling 55 samples).
• Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ): Investigated following CLSI standard EP17-A.
• Analytical Specificity (Cross-reactivity): Panel of 65 clinically characterized sera.
• Analytical Specificity (Interference): Sera with anti-PLA2R concentrations spiked with potential interfering substances.
• Method Comparison and Clinical Study:
  • Test Set Size: 560 samples in total; 275 from pMGN patients and 285 from control groups.
  • Data Provenance: The document states "Clinical studies were performed in cooperation with different sites." While specific countries are not mentioned, it implies multiple clinical sites. The studies are prospective in nature in the sense that samples were collected for analysis by the new device against established clinical diagnoses. The clinical diagnoses were based on renal biopsy and clinical/laboratory criteria, and samples were drawn within 8 weeks after biopsy before treatment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical study samples.
• However, the clinical study section states: "pMGN diagnosis was based on renal biopsy and was considered to be idiopathic/primary when no secondary cause of MN was suspected on the basis of clinical and laboratory criteria." This implies a standard clinical diagnostic process involving medical professionals (e.g., nephrologists, pathologists) who interpret biopsies and clinical data.

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method for the clinical study's ground truth beyond stating that pMGN diagnosis was "based on renal biopsy and was considered to be idiopathic/primary when no secondary cause of MN was suspected on the basis of clinical and laboratory criteria." This suggests that the clinical diagnosis, informed by biopsy and other findings, served as the ground truth. There is no mention of a process like "2+1" or "3+1" for reaching a consensus diagnosis for individual cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This information is not applicable to the EUROIMMUN Anti-PLA2R ELISA (IgG) device. This is an in vitro diagnostic (IVD) assay, not an AI-powered image analysis or diagnostic support system that would involve human readers and AI assistance. The performance is measured directly through laboratory analysis of patient samples.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• This is an in vitro diagnostic (IVD) assay (ELISA), not an algorithm or AI system. The performance characteristics (sensitivity, specificity, reproducibility, etc.) are inherent to the assay and its protocol when performed in a laboratory setting. Therefore, a "standalone algorithm performance" study is not relevant in this context. The results are generated by the assay itself, following the prescribed procedure, and then interpreted based on established cut-off values.

7. The Type of Ground Truth Used

• Clinical Study: The ground truth for the clinical study samples was based on clinical diagnosis, primarily established by:
  • Renal biopsy for confirmation of primary membranous glomerulonephritis (pMGN).
  • Clinical and laboratory findings to rule out secondary causes of membranous nephropathy.
• Analytical Studies (e.g., Reproducibility, Linearity, Cross-reactivity, Interference): The ground truth for these studies was based on:
  • Known concentrations or expected relative values of analytes in prepared samples or controls.
  • Known clinical characteristics of patient panels (e.g., positive for thyroiditis, negative for anti-PLA2R antibodies, etc.).

8. The Sample Size for the Training Set

• This is an in vitro diagnostic (IVD) assay, not a machine learning or AI model that requires a distinct "training set" in the traditional sense. The device's performance characteristics are established through various analytical and clinical studies, but there isn't a "training phase" to optimize an algorithm with a specific dataset.

9. How the Ground Truth for the Training Set was Established

• As explained above, this device is not an AI/ML algorithm requiring a training set. The "ground truth" equivalent for the development and validation of an IVD assay involves:
  • Reference materials/calibrators: Precisely prepared solutions with known concentrations of the analyte.
  • Clinically characterized samples: Sera from patients with confirmed diagnoses (e.g., pMGN by biopsy, specific autoimmune diseases) and healthy controls, used to determine the assay's clinical performance. These samples are analogous to validation data for an algorithm.

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The EUROIMMUN Anti-Glutamate receptor (type NMDA) IFA is intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. It is used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings.

The EUROIMMUN IFA is an assay for standardized detection of anti-glutamate receptor (type NMDA) antibodies utilized in each laboratories familiar with indirect immunofluorescence. The non-transfected cells are used as a control to simplify differentiation of potential co-existing and non-specific reactivity such as ANA. The test kit consists of slides, which contain BIOCHIPs coated with glutamate receptor (type NMDA) transfected cells and non-transfected cells, fluorescein-labelled anti-human IgG (goat), a positive control for transforced volle and non new and of a negative control, a salt for preparation of PBS, Tween 20, embedding medium, cover glasses and an instruction booklet.

The acceptance criteria and study proving the device meets them are detailed below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for sensitivity and specificity. However, based on the studies presented, we can infer the desired clinical performance. The reported device performance is directly from the clinical studies.

Note: The "acceptance criteria (inferred)" are based on typical expectations for diagnostic assays intended to aid in diagnosis. The document does not provide specific numerical targets prior to presenting the results.

2. Sample Sizes Used for the Test Set and Data Provenance:

The 'test set' for clinical performance was composed of samples across four clinical studies. The data provenance includes both retrospective and prospective elements.

• Study 1: 47 serum samples (29 anti-glutamate receptor (type NMDA) encephalitis, 18 other encephalopathies) from the US (Prospective, though the specific collection method isn't detailed, it implies collection for diagnostic purposes). Additionally, 100 adult healthy blood donors from Germany (Prospective/Retrospective, general population screening).
• Study 2: 2990 patients screened for encephalitis of unknown origin; 6 samples ultimately tested (6 women) from Germany (Retrospective).
• Study 3: 8 samples from patients with anti-glutamate receptor (type NMDA) encephalitis from Germany (Prospective/Retrospective, not explicitly stated).
• Study 4: 9 samples from patients with anti-glutamate receptor (type NMDA) encephalitis and 13 from patients with other encephalopathies from Italy (Prospective/Retrospective, not explicitly stated).

Combined Test Set Sample Sizes:

• Positive cases (anti-NMDA encephalitis): 29 + 5 (from 6) + 8 + 9 = 51 (overall 52 based on table summary, possibly one case from study 2 was reclassified as positive, or a rounding difference)
• Negative cases (other encephalopathies/healthy donors): 18 + 100 + 13 = 131

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the number of experts or their qualifications who established the ground truth for the test set. It mentions "patients diagnosed with anti-gluatamate receptor (type NMDA) encephalitis" and "controls with other encephalopathies," implying established clinical diagnoses. It also states the device is used "in conjunction with other laboratory and clinical findings," suggesting that the ground truth patients were diagnosed by a combination of clinical specialists (e.g., neurologists) and potentially other laboratory tests, but the specific expert review process for the test set is not detailed.

4. Adjudication Method for the Test Set:

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set cases. The cases are described as "patients diagnosed with," implying that their diagnosis served as the ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

The document describes an indirect immunofluorescent antibody assay (IFA) which is a laboratory test requiring visual interpretation by a human. However, it does not involve AI or a multi-reader, multi-case (MRMC) comparative effectiveness study of human readers with or without AI assistance. The device is not an AI-based diagnostic tool for image analysis as described in the context of improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The device is an IFA kit, which inherently requires human interpretation of fluorescence under a microscope. It is not an algorithm that performs standalone analysis.

7. The Type of Ground Truth Used:

The ground truth used for the clinical studies appears to be based on clinical diagnosis of anti-glutamate receptor (type NMDA) encephalitis or other encephalopathies. For healthy controls, the implied ground truth is the absence of the disease. The phrase "patients diagnosed with" suggests a consensus among clinicians and potentially other diagnostic tests, but not explicitly pathology or a specific "outcomes data" in the sense of long-term follow-up beyond diagnosis.

8. The Sample Size for the Training Set:

The document does not describe a specific "training set" for the device, as it is a laboratory assay (IFA kit) rather than a machine learning or AI algorithm that requires a separate training phase with labeled data. The development of the assay likely involved internal optimization and validation, but this is not referred to as a "training set" in the context of device performance testing.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as a distinct training set (in the context of machine learning) is not described for this IFA kit.

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The EUROIMMUN Anti-Desmoglein 1 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against desmoglein 1 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus .foliaceus (PF), in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IqG class autoantibodies against desmoqiein 3 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus vulgaris (PV), in conjunction with other laboratory and clinical findings.

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The provided document is a 510(k) premarket notification letter from the FDA for an in vitro diagnostic (IVD) device, the EUROIMMUN Anti-Desmoglein 1 ELISA (IgG) and EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kits. While it indicates substantial equivalence to a predicate device and lists the indications for use, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The FDA letter is a regulatory document confirming clearance, not a technical study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, which means its performance is considered comparable to already approved tests. To provide the requested information, one would typically need access to the actual 510(k) submission, specifically the sections detailing the analytical and clinical performance studies.

Therefore, for almost all points requested, the answer is "Information not provided in the given text."

However, based on the nature of the device (IVD for antibody detection), we can infer some general aspects and what kind of study would typically be conducted, even if the specifics aren't here.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Information not provided in the given text. This would typically include metrics like sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), often with confidence intervals, compared against pre-defined thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Information not provided in the given text. For an IVD, the test set would typically involve a cohort of patients with and without the target condition (Pemphigus foliaceus or Pemphigus vulgaris) to evaluate diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Information not provided in the given text. For IVDs, the "ground truth" (or reference method) is often established by a combination of clinical diagnosis, other established laboratory tests, and sometimes biopsy/histopathology interpreted by specialists (e.g., dermatologists, pathologists). The number and qualifications of these experts would be detailed in the study report.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Information not provided in the given text. Adjudication methods are more common in imaging studies or clinical trials where expert consensus is needed. For an IVD, the "ground truth" is typically established by definitive diagnostic methods rather than subjective reader consensus on the test results themselves.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• N/A – This is not applicable to an IVD ELISA test kit. MRMC studies and AI assistance are relevant for image-based diagnostic systems where human interpretation is a key component. This device is an immunoassay, which generates quantitative or semi-quantitative antibody levels, and does not involve "human readers" in the same sense as an imaging study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, this is a standalone device. An ELISA test kit is designed to provide a result (qualitative or semi-quantitative) based on a laboratory procedure, without direct human-in-the-loop interpretation impacting the primary test result. The "algorithm" here is the assay's biochemical reaction and detection method, and the cutoff values defining positive/negative results. Its performance is assessed independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Information not provided in the given text. For an anti-desmoglein antibody test, the ground truth for positive cases would typically be a definitive clinical diagnosis of Pemphigus foliaceus (PF) or Pemphigus vulgaris (PV) confirmed by established diagnostic criteria, which often includes histological findings from biopsy (pathology) and direct/indirect immunofluorescence, in addition to clinical presentation. Negative cases would be from healthy controls or patients with other dermatological conditions.

8. The sample size for the training set

• Information not provided in the given text. For IVDs, the concept of a distinct "training set" and "test set" as typically used in machine learning might not be explicitly separated in the same way. There would be samples used during assay development, optimization, and initial analytical validation (which could loosely be considered "training"), and then a separate clinical validation set (the "test set"). The document does not specify either.

9. How the ground truth for the training set was established

• Information not provided in the given text. Similar to point 7, the ground truth for any samples used during development would also be established by definitive diagnostic criteria for the respective conditions.

In summary, the provided FDA clearance letter indicates the device's intended use and regulatory status but does not contain the detailed performance data or study design specifics. These details would be found in the manufacturer's 510(k) submission, specifically the sections dedicated to analytical and clinical performance studies.

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The EUROIMMUN Anti-M2-3E ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against the mitochondrial antigens M2 in human serum and plasma. It is used as an aid in the diagnosis of primary billary cirrhosis (PBC), in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-M2-3E ELISA (IgG) consists of a microwell ELISA plate coated with M2-3E antigen, 3 calibrators, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.

The provided text describes the performance characteristics of the EUROIMMUN Anti-M2-3E ELISA (IgG) test kit and its comparison to a predicate device and clinical studies. However, it does not explicitly define "acceptance criteria" in a separate section with specific numerical thresholds for each performance metric before presenting the study results. Instead, the "Performance Characteristics" section M presents the study results for analytical and clinical performance.

Based on the information provided, I will infer what constitutes "acceptance criteria" from the reported performance, especially for the "Method comparison with predicate device" and "Clinical studies" sections, where the device needs to show substantial equivalence or good diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Inferred Acceptance Criteria:

• Precision/Reproducibility: Intra-assay and Inter-assay CVs < 12% for positive samples. Lot to lot CV < 12% for positive samples.
• Linearity/Assay Reportable Range: Observed/Expected (O/E) values in the cut-off should be within 0.8 to 1.2.
• Interference: Recovery in relation to unspiked sample should be within 98-123%.
• Method Comparison (with predicate): High positive and negative agreement, and high overall agreement with the predicate device. For the 127 samples, overall agreement > 90%
• Clinical Sensitivity (for PBC): High sensitivity (e.g., >90%).
• Clinical Specificity: High specificity (e.g., >90%) across various control groups.

Reported Device Performance:

2. Sample sizes used for the test set and the data provenance

• Precision/Reproducibility:
  • Intra-assay: 12 unique samples, each tested 20 times.
  • Inter-assay: 12 unique samples, each tested 4 times over 6 days (total 24 determinations per sample).
  • Lot to Lot: 8 unique samples, each tested across 3 different lots and 2 runs (total 6 determinations per sample).
• Linearity: 5 patient sera, each serially diluted up to 1/32, with single determinations.
• Analytical Specificity (Cross-reactivity): 29 sera (10 PCA, 10 GBM, 9 LKM positive).
• Interference: 5 different specimens at varying Anti-M2-3E concentrations, spiked with potential interfering substances.
• Method Comparison with Predicate Device: 127 clinically characterized samples (39 AIH, 49 PBC, 32 AIH/PBC overlap, and 7 created "borderline" samples by mixing) collected at EUROIMMUN UK Ltd. This data appears to be retrospective as samples were already "clinically characterized."
• Matrix Comparison: 21 sample pairs of serum and corresponding plasma.
• Clinical Studies: 1180 clinically characterized samples (251 from PBC patients and 929 from control groups). The text mentions "performed in cooperation with several university hospitals," suggesting retrospective collection of already diagnosed patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts used to establish the ground truth, nor their qualifications for any of the studies (method comparison or clinical studies). It states samples were "clinically characterized" for the method comparison and "clinically characterized" for the clinical study, but does not detail the process or who performed it.

4. Adjudication method for the test set

The document does not describe any adjudication method for establishing the ground truth for either the method comparison or the clinical studies. Ground truth appears to be based on "clinical characterization" which typically implies diagnosis based on multiple clinical and laboratory findings, but the specific process for confirming these diagnoses is not elaborated.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to the provided document. The device is an in vitro diagnostic ELISA test kit, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI assistance. The performance is based on the assay's ability to detect autoantibodies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the studies presented are all standalone performance evaluations of the EUROIMMUN Anti-M2-3E ELISA (IgG) test kit. The performance characteristics (analytical and clinical) measure the device's ability to detect specific autoantibodies directly, without human interpretation of the assay's output other than reading the optical density and interpreting the result against the established cutoff.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical studies appears to be based on clinical diagnosis of Primary Biliary Cirrhosis (PBC) and various control conditions. The phrase "clinically characterized samples" implies that these diagnoses were established through a combination of clinical findings, patient history, other laboratory tests, and possibly biopsy/pathology results, as part of routine medical practice at the "several university hospitals." However, specific details like "expert consensus" or "pathology" are not explicitly mentioned as the sole or primary ground truth source.

8. The sample size for the training set

The document does not mention a distinct "training set" in the context of machine learning or algorithm development. The ELISA test kit is a biochemical assay. The "calibrators" are used to establish a calibration curve for quantitative or semi-quantitative results, and "controls" are used for quality assurance, but these are not a "training set" in the AI/ML sense. The product development would involve internal validation and optimization, but specific "training set sizes" are not provided.

9. How the ground truth for the training set was established

As there is no "training set" in the context of an algorithm, this question is not applicable. For the calibrators and controls included in the kit, their "ground truth" (i.e., their known concentration or reactivity level) is established during the manufacturing and quality control processes of the diagnostic kit.

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The Anti-Gliadin (GAF-3X) ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

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The provided text is an FDA 510(k) clearance letter and an "Indications for Use" statement for the EUROIMMUN US INC. Anti-Gliadin (GAF-3X) ELISA (IgG) device. It does NOT contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for a study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text.

The document indicates that the device has received 510(k) clearance based on its substantial equivalence to a legally marketed predicate device. This type of clearance does not typically involve the detailed performance study and acceptance criteria reporting that you are asking for in the same way a PMA (Pre-Market Approval) submission would, or as you might see for a diagnostic AI/ML device where performance metrics against a defined ground truth are central.

To answer your questions, one would need to access the actual 510(k) submission document (K083053), which would contain the performance data and the comparison to the predicate device that led to the substantial equivalence finding.

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The Anti-Gliadin (GAF-3X) ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

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This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically an ELISA test. These types of clearances typically do not involve the kind of AI/ML performance acceptance criteria and study designs described in the prompt. The information requested, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance for AI, are not applicable to the clearance of this type of device.

Instead, for IVD devices like the Anti-Gliadin (GAF-3X) ELISA (IgA), the acceptance criteria and supporting studies usually focus on analytical performance (e.g., sensitivity, specificity, accuracy against a predicate device or clinical diagnosis), precision, linearity, and interference studies.

Therefore, I cannot provide the requested information in the format of the prompt because it describes criteria and studies relevant to AI/ML medical devices, not to an ELISA test cleared via a 510(k) pathway as described in the provided document.

The document indicates:

• Device Name: Anti-Gliadin (GAF-3X) ELISA (IgA)
• Intended Use: Qualitative determination of IgA class antibodies against gliadin in human serum as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.
• Regulatory Class: II
• Product Code: MST
• Predicate Device: Not explicitly detailed in the provided excerpt, but it is implied that the device demonstrates substantial equivalence to a legally marketed predicate.

To provide information analogous to the prompt's request for an IVD ELISA test, one would look for data on diagnostic sensitivity, specificity, and agreement with a reference method or predicate device, typically found in the 510(k) summary if available, or the full submission. However, this level of detail is not present in the provided FDA clearance letter itself.

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The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or qualitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and EDTA or citrate plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

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The provided text is a letter from the FDA regarding the 510(k) premarket notification for the EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) device. While it states that the device is substantially equivalent to a predicate device and can be marketed, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance study details.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided text.

The document primarily focuses on regulatory approval and classification, not on the technical details of the validation study.

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The EUROIMMUN Anti-PR3-hn-hr ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against proteinase 3 (PR3) in human serum, EDTA plasma, lithium heparin plasma and citrate plasma. It is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.

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This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain the detailed information necessary to complete the requested table and study description. The letter states that the device is substantially equivalent to a legally marketed predicate device but does not provide specific acceptance criteria or the study details that prove the device meets these criteria. Such information is typically found in the 510(k) summary or the full submission, which are often available separately.

Therefore, I cannot fulfill your request with the provided text.

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The EUROIMMUN Anti-BP180-4X ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against BP180 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid (PB), in conjunction with other laboratory and clinical findings.

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This is a 510(k) premarket notification decision letter, not a study report. It does not contain the detailed information about acceptance criteria or specific study results to prove device performance. The letter only states that the device is "substantially equivalent" to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the text provided. The document primarily focuses on regulatory approval and classification, not on the individual studies proving performance.

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